NCT01948856

CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,003 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.

Conditions

• Recurrent Upper-Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	J022X ST	Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals
DRUG	Placebo	Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-10-17
• Completion: 2016-12-13
• First posted: 2013-09-24
• Last updated: 2017-02-03

Locations

24 sites across 5 countries: Italy, Lithuania, Poland, Romania, Russia